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The Sr. Automation Engineer (Utilities) is a member of the ADL Plant Automation Team and supports the day-to-day operation, reliability, and compliance of Amgen’s utility and building automation systems. The role is a System Owner for both Siemens Desigo CC and Siemens PLC systems, ensuring uptime, compliance, and continuous improvement in a GMP-regulated environment.
Job Responsibility:
Act as System Owner for automation systems in a GMP-regulated manufacturing setting, overseeing lifecycle maintenance and validation
Manage Change Controls, Deviations, and CAPAs associated with Automation Systems
Maintain robust system documentation, configuration control, and software versioning
Provide on-the-floor and remote technical support to operations and engineering during production, shutdowns, and technology transfers
Lead or support incident investigations and root cause analyses for automation-related issues
Implement CAPAs, including software changes and updates to design documentation and SOPs
Analyse current system designs and recommend improvements aligned with the latest technology and regulatory standards
Champion Industry 4.0 initiatives, including data integration, advanced analytics, and digital twin technologies
Support new product or technology introductions by performing engineering assessments, implementing automation system changes, and supporting engineering runs
Work closely with cross-functional teams, stakeholders, and vendors to achieve common goals and deliver projects efficiently
Promote a culture of safety and regulatory compliance across all activities
Always Ensure adherence to EHS and GMP policies
Requirements:
Bachelor’s degree in Mechatronic Engineering, Automation Engineering, Control Engineering or related life science engineering with 5+ years’ experience in operations/manufacturing environment
Background in automation design, installation, validation, lifecycle management, testing and programming
Experience in Building Management Systems (Siemens Desigo)
Experience in Siemens S7-300/400/1200/1500 PLCs
Experience in Siemens HMIs
Experience in Siemens Desigo PXC series
Experience in Siemens Desigo CC
Experience in Profinet, Profibus, Modbus TCP, BACnet, OPC UA
Experience in SQL Database
Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11
Support integration of utilities data into AVEVA PI System and analytics dashboards
Working knowledge of network architecture technologies including TCP/IP and Firewalls
Work independently, stay organized, and manage several tasks in a busy manufacturing setting
Be a supportive team player who values teamwork and collaboration
Strong technical writing, communication, and presentation skills
Build good relationships and work with teams from different areas to reach shared goals
Travel at various times may be required to support training and vendor visits